Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-02 @ 4:22 PM
Study NCT ID:
NCT00413933
Status:
TERMINATED
Last Update Posted:
2016-04-21
First Post:
2006-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Intervention for Falls Prevention in the Elderly
Sponsor:
Soroka University Medical Center
Organization:
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2006-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was stopped due to lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the comprehensive multidisciplinary intervention (geriatrician, physical therapist and occupational therapist falls risk assessment and intervention)is effective in the falls prevention in the community dwelling elderly.
Detailed Description:
Falls and related injuries among elderly people are a major public health problem worldwide.All older people with recurrent falls or assessed as being at increased risk of falling should be considered for an individualized multifactorial intervention.
In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:
* exercise
* home hazard assessment and intervention
* vision assessment and referral
* medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.
In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.
Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU\&G).
Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group. All participants will be instructed to call to the research assistant closely to each fall.
All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.
A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.
According to this plan each patient in this group will receive one or more following interventions:
1. Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
2. Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
3. Physical therapy: each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions.
4. Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.
First follow-up (four months after baseline assessment):
1. OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
2. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU\&G and visual assessment by Snellen chart).
3. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
4. Information about medication adjustment and changes will be collected from Clalit computerized system.
Second follow-up (12 months after baseline assessment ) :
1. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
2. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
3. Information about medication adjustment and changes will be collected from Clalit computerized system.
In successful multifactorial intervention programmes the following specific components are common - against a background of the general diagnosis and management of causes and recognized risk factors:
* exercise
* home hazard assessment and intervention
* vision assessment and referral
* medications list review with modification/withdrawal We will address to 4000 randomly chosen patients from study population (elderly (65+) men and women, living in Beer-Sheva and Ofakim , Israel and belonging to Clalit HMO). This telephone interview will be conducted to reveal falls in last 12 months. The people who do fall (1 + falls) will be invited to research assistant.
In that meeting the research assistant will explain about the study aims and ask them to sign informed consent. Those who do not agree to participate - will be referred to their family doctor for further assessment.
Those who agree to participate in the study will fill in questionnaire about falls (causes, circumstance, results). All will pass through: cognitive assessment by the Mini-Mental State Examination (MMSE), affective assessment by the 15-item Geriatric Depression Scale (GDS), functional assessment by Barthel Index (BI), visual assessment by Snellen charts and basic gait assessment by a "Timed get Up and Go" test (TU\&G).
Participants that fulfill inclusion criteria will be randomly assigned to the intervention group or the control group. All participants will be instructed to call to the research assistant closely to each fall.
All information about assessment of patients in both groups will be transferred to the family physician. Their family physician according to his opinion will treat patients from usual care group.
A geriatrician, physiotherapist and occupational therapist will observe patients in the intervention group. OT will conduct a home visit to assess hazard and level of risk factor for falling. Results of assessment will be discussed on multi- disciplinary team meeting.
According to this plan each patient in this group will receive one or more following interventions:
1. Written recommendation to the family physician for medication adjustment. As well, the geriatrician will discuss with family physician these recommendations.
2. Recommendation to the family physician to refer the patient to optometrist/ ophthalmologist.
3. Physical therapy: each subject in intervention group will get 15 weekly sessions (each session - 45 minutes) of specified exercise from a physical therapist that specializes in fall prevention and walking device recommendations. All subjects will get brochure for home exercise. It will be expected for intervention group to exercise twice daily, each time for 20 minutes in addition to the PT sessions.
4. Occupational therapy: OT will make recommendation for changing any unsafe environments in the home.
First follow-up (four months after baseline assessment):
1. OT will make a second home visit to each subject of the intervention group to check recommendation fulfillment.
2. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TU\&G and visual assessment by Snellen chart).
3. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
4. Information about medication adjustment and changes will be collected from Clalit computerized system.
Second follow-up (12 months after baseline assessment ) :
1. Study assistant will repeat baseline assessment (MMSE, GDS, BI, TUG test and visual assessment by Snellen chart).
2. Information about falls and injuries as well as health care utilization will be collected from Clalit computerized system and Soroka Medical Center data base.
3. Information about medication adjustment and changes will be collected from Clalit computerized system.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: